Alternate Day Fasting, Exercise, and NAFLD

Not Applicable

Completed

Conditions: Non-Alcoholic Fatty Liver Disease
Obesity

Registration Number: NCT04004403

Lead Sponsor: University of Illinois at Chicago

Brief Summary: Approximately 65% of obese individuals have non-alcoholic fatty liver disease (NAFLD), and this condition is strongly related to the development of insulin resistance and diabetes. Innovative lifestyle strategies to treat NAFLD are critically needed. The proposed research will demonstrate that alternate day fasting (ADF) combined with exercise is an effective non-pharmacological therapy to treat NAFLD.

Detailed Description: Nonalcoholic fatty liver disease (NAFLD) is characterized by an accumulation of fat in the liver (not resulting from excessive alcohol consumption). Approximately 65% of obese individuals have NAFLD, and this condition is strongly related to the development of insulin resistance and type 2 diabetes. While certain pharmacological agents have been shown to reduce liver fat (i.e. thiazolidinediones), there is mounting concern regarding the safety and weight-gaining effects of these compounds. In light of this, recent research has focused on non-pharmacological lifestyle therapies to reduce hepatic steatosis, such as daily calorie restriction combined with aerobic exercise. Evidence from clinical trials suggest that this combination is an effective lifestyle therapy improve liver fat content and hepatic insulin sensitivity.

More recently, it's been shown that intermittent fasting may produce even greater improvements in hepatic steatosis and hepatic insulin sensitivity, when compared to conventional calorie restriction. For instance, intrahepatic lipid accumulation was lower and insulin sensitivity was higher in mice fasted every other day, when compared to mice who were energy restricted every day. Moreover, data from human trials show that adults with obesity experience greater decreases in insulin and insulin resistance with intermittent fasting versus daily restriction. These findings suggest that intermittent fasting may be a more effective diet therapy to reduce hepatic steatosis and improve insulin sensitivity, when compared to daily calorie restriction. Although these findings are very promising, these data still require confirmation by a randomized controlled clinical trial.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Hepatic Steatosis	Change from week 1 to week 12	Hepatic steatosis will be measured by magnetic resonance imaging (MRI-PDFF)

Secondary Outcome Measures

Name	Time	Method
Change in Body Weight	Change from week 1 to week 12	Measured by digital scale
Change in Alanine Aminotransferase (ALT)	Change from week 1 to week 12	Measured by a commercial lab (Medstar, Inc)
Change in Aspartate Aminotransferase (AST)	Change from week 1 to week 12	Measured by a commercial lab (Medstar, Inc)
Change in Fasting Glucose	Change from week 1 to week 12	Measured by a commercial lab (Medstar, Inc)
Change in Fasting Insulin	Change from week 1 to week 12	Measured by a commercial lab (Medstar, Inc)
Change in Insulin Resistance	Change from week 1 to week 12	Measured by Homeostatic model assessment of insulin resistance (HOMA-IR). The HOMA-IR value was calculated using the formula: \[HOMA-IR = glucose (mg/dL) × insulin (mU/L)/405\]. Interpretation of HOMA-IR Scores: \< 1.0: Normal insulin sensitivity; 1.0-1.9: Mild insulin resistance; \> 2.0: Moderate to severe insulin resistance.
Change in HbA1c	Change from week 1 to week 12	Measured by a commercial lab (Medstar, Inc)

Trial Locations

Locations (1): University of Illinois Chicago
🇺🇸
Chicago, Illinois, United States
University of Illinois Chicago
🇺🇸Chicago, Illinois, United States